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Request for a Screening for Exemption
for the Use of Human Subjects in Non-Medical Research
This form should NOT be used if your research activities will be limited to the secondary analysis of
existing data. Use the Request for Protocol Approval for Secondary Analysis of Existing Data.
Contents:
A. Investigator and Project Information
B. Investigator Assurances
C. Instructions for Preparing Project Description
A. Investigator and Project Information
Investigator: DEL-MEM Student Name
Status: [ ] Faculty [ x] Graduate Student [ ] Undergraduate [ ] Other: ________________________
Department/School: The Nicholas School DEL-MEM Program
E-mail: [email protected]
Phone: XXX-XXX-XXXX Campus PO Box No. ____N/A______
Faculty Advisor for Graduate and Undergraduate Students:
Dr. Deborah Rigling-Gallagher
E-mail: [email protected] Phone: (919) 613-8138 Campus PO Box No. 90328
Project Title: Implementation Effectiveness of Corporate Environmental Policies and Strategies
Source of Funding: N/A
(If research is externally funded, submit a copy of the application or the award.)
Proposal/Grant No. for Federally funded research: N/A
Research Site: Three to five international companies and organizations, electronic surveys
Subject Population: Please check all that apply.
[ ] Duke employees [ ] Minors, as defined at research site (under 18 years old in NC)
[ ] Duke students
[ ] Duke Psychology Subject Pool [ ] Students or employees of the researcher [ ] Prisoners
Page 1 of 11 5/27/2004
B. Assurances
(Original signatures are required*)
Investigator(s) Assurance:
I certify to the following:
1. The research will not be initiated until written approval is secured from the IRB. (Note: Approval
will not be provided unless certification to conduct research with human subjects is current for
the investigator(s), and if the investigator is a student, the advisor’s certification is also current.)
2. I will conduct this study as described in the approved protocol. If any changes are anticipated, I will
contact the IRB staff prior to implementing the changes. I will contact the IRB staff immediately if any
of the following events occur: unanticipated risks, adverse events, and findings during the study that
would affect the risks or benefits.
___________________________________
Investigator
___________________________________
Investigator
________
Date
________
Date
Faculty Advisor Assurance (Required for Graduate or Undergraduate Student Research):
I certify that I have reviewed and approved the student research plan. I assume responsibility for 1)
ensuring that student researchers are aware of their responsibilities as investigators, and 2) that the IRB
will be immediately informed in the event of research- related unanticipated risks, adverse events, or
findings during the study that would affect the risks or benefits of participation.
___________________________________
Advisor
___________________________________
Advisor
________
Date
________
Date
Approval of the Department Chair or School Dean:
___________________________________ Date ________
Chair or Dean
============================================================================
APPROVAL: ___________________________________ Date ________
Human Subjects Administrator or IRB Member
*Protocols may be reviewed with faxed signatures, but originals are needed for final approval.
Page 2 of 11 5/27/2004
C. Category of Activity
Please select the exemption that applies to your project. If the project includes any research activity with
human subjects not specifically exempted under one or more of the exemption criteria, IRB review is
required. Be sure to consult the FAQs for Exempt Research regarding restrictions on the use of
exemptions even when the research activity falls into one of the categories listed.
The activities eligible for exemption are inherently risk free. If your study involves risks that must
be managed, either through confidentiality procedures or services such as referral, it is not eligible
for exemption.
The categories are listed in the order most often used by researchers in the social and behavioral sciences.
Sponsors may want you to identify the federal number for the category used to exempt your research so
the numbers are supplied at the end of each category.
_X__
Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement),
survey procedures, interview procedures, observation of public behavior, unless the information is
obtained and recorded in such a manner that the human subjects can be identified, directly or through
identifiers linked to the subjects; and any disclosure of the human subjects’ responses outside the
research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the
subjects’ financial standing, employability, or reputation. (Category 2.)
___ Research conducted in established or commonly accepted educational settings, involving normal
educational practices, such as (i) research on regular and special education instructional strategies, or
(ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or
classroom management methods. (Category 1.)
___ Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey
procedures, or observation of public behavior that is not exempt under item (2) above; if the human
subjects are elected or appointed public officials or candidates for public office; or federal statute(s)
require without exception that the confidentiality of the personally identifiable information will be
maintained throughout the research and thereafter. (Category 3)
___ Research and demonstration projects which are conducted by or subject to the approval of
Department or Agency heads, and which are designed to study, evaluate, or otherwise examine
methods and procedures of public benefit or service programs. (For example, a study of identifiable
welfare data.) (Exemption No. 5)
___ Taste and food quality evaluation and consumer acceptance studies, if wholesome foods without
additives are consumed, or a food is consumed that contains a food ingredient at or below the level
and for a use found to be safe, or an agricultural chemical or environmental contaminant at or below
the level found to be safe, by the FDA or approved by the EPA or the USDA. (Category 6)
The secondary analysis of pre-existing data (Exemption Category No. 4) requires the use of a separate
form.
Page 3 of 11 5/27/2004
D. Instructions for Preparing the Project Description
General Guidelines:
The primary concern of the IRB is the experience of your subjects. Provide sufficient information for the
reviewers to be able to describe that experience from the recruitment stage to the dissemination of your
results.
The research description should be free of discipline-specific jargon whenever possible.
To assist in review, sections of your project description should be titled according to the three categories
described below. Please use page numbers.
Questions are provided in each category of information. Though not inclusive, the questions are designed
to solicit the detail the reviewer will need. It may be appropriate for you to provide additional information.
Some questions may not be applicable to your research. Incorporate your answers to relevant
questions in a narrative response to each category.
Research Description:
1. Research Design



What is the purpose of the study? Provide background information when appropriate.
In what activities will subjects participate? How long will each activity take? (In some field work,
including ethnography, time estimates need only be provided for formal interviews.)
o Describe and attach surveys, questionnaires, and interview schedules.
o If you plan to conduct informal interviews, life histories or other “organic” interviews,
provide a description of the topics you will address or sample questions.
o If the study involves observation, describe the events to be observed and the setting.
Will you collect identifiable data? Please describe.
2. Subject Selection



What is your proposed subject population?
How will your subjects be identified and recruited?
If not the researcher, who will make the initial contact with the subjects?
o Attach copies of any recruitment materials you propose to use such as posters, flyers, or
newspaper ads. (Flyers recruiting Duke students must stipulate that subjects must be at
least eighteen years of age.)
3. Informed Consent
Attach an Informed Consent form of your own design for each subject population or, if appropriate,
provide a script for an oral consent process. (See guidelines below.)
If your subjects will be children (less than eighteen years old in North Carolina) design a parental
permission process and describe how you will secure assent of the children.
Page 4 of 11 5/27/2004
Guidelines for Informed Consent in Exempt Research
Potential subjects must be fully informed about the research in a manner comprehensible to them
and then allowed to choose whether to participate in the research.
Information:
The following elements of consent need to be included in every consent process, written or
oral, with few exceptions:
An explanation about who you are, your affiliation with Duke, and the
organization(s) sponsoring the research
The purpose of the research
What you will ask subjects to do and how long it will take
A clear statement that participation is voluntary and that subjects may choose to
withdraw at any time or choose not to answer every question
A statement about what you intend to do with the information subjects provide you.
(How long will you keep it? How will you report on it? Who will have access to
it?)
A description of any compensation that will be offered to each subject and of the
conditions under which they will receive partial or no payment
Contact information for you, and others as appropriate
Comprehension:
What is the reading level of your potential subjects? Is the consent form written at
the appropriate level?
Is the language culturally appropriate?
If not English, what is the primary language of your subjects? Are you fluent in
that language or do you have interpreters?
Voluntary Participation:
If applicable, please address how you will eliminate the possibility of real or
perceived coercion of potential subjects.
Are their cultural issues limiting free choice to participate in research and, if so,
how will you address them?
Page 5 of 11 5/27/2004
Research Design

What is the purpose of the study? Provide background information when appropriate.
Conservation International is working with numerous companies to support their development and
implementation of environmental policies and strategies. Several years into this collaborative approach,
little effort has been placed on a formal evaluation of how effectively these policies and strategies are being
implemented, and what positive, measurable impact, if any, this has had on achieving biodiversity
conservation outcomes. Therefore, evaluation of a select number of companies with whom CI has worked
for several years to determine how effective their environmental policy and strategy implementation has
been, and any linkages to achieving biodiversity conservation results, will be useful in informing the future
work of CI, NGOs engaging business to advance their missions, and businesses striving to meet their
environmental responsibilities. The particular study objectives are as follows:
 To evaluate how effective CI has been in achieving its conservation mission through engaging the
business sector through its corporate partnerships;
 To make recommendations for how CI can design and implement corporate partnership so they are
optimally effective; and
 To make recommendations for how companies can best design and execute environmental policies and
strategies that achieve biodiversity conservation results.

In what activities will subjects participate? How long will each activity take? (In some field work,
including ethnography, time estimates need only be provided for formal interviews.)
o Describe and attach surveys, questionnaires, and interview schedules.
o If you plan to conduct informal interviews, life histories or other “organic” interviews,
provide a description of the topics you will address or sample questions.
o If the study involves observation, describe the events to be observed and the setting.
Study participants will receive a survey (see questions below) electronically. They will be
contacted via telephone if needed to prompt a survey response and if there is any clarification
needed on their survey responses. All questions to corporate participants will focus on their design
and execution of environmental policies and strategies and achievement of biodiversity
conservation results. All questions to CI participants will focus on design and execution of
institutional corporate partnerships and achievement of conservation results.

Will you collect identifiable data? Please describe.
Names of interviewees and their employers will appear in the text where appropriate, unless asked
not to. If an interviewee does not want their name or company name to appear, it will not appear in
text or reference material. “Appropriateness” in this case consists of the following standard: if the
idea expressed by the interviewee is original enough to warrant a source note, then interviewee’s
name will appear in either the body of the text or (by necessity) the source note, unless interviewee
requests anonymity. This should not be the case since the questions will not focus on personal
opinion, just the policies and culture of the companies or organization.
Subject Selection

What is your proposed subject population?
Page 6 of 11 5/27/2004
The project will focus on three to five different multinational mining companies with which CI has
partnered on development and implementation of environmental policies and strategies, as well as
CI. The subjects will be those employees that are designated to speak on this topic, from corporate
and business unit / field office levels within the companies and CI.

How will your subjects be identified and recruited?
Participants will have knowledge of their company’s, or CI’s work with those companies,
environmental policies and strategies, and implementation. Participants will initially be contacted
by email.

If not the researcher, who will make the initial contact with the subjects?
Attach copies of any recruitment materials you propose to use such as posters, flyers, or
newspaper ads. (Flyers recruiting Duke students must stipulate that subjects must be at
least eighteen years of age.)
No others will recruit.
Informed Consent
Attach an Informed Consent form of your own design for each subject population or, if appropriate,
provide a script for an oral consent process. (See guidelines below.)
If your subjects will be children (less than eighteen years old in North Carolina) design a parental
permission process and describe how you will secure assent of the children.
Page 7 of 11 5/27/2004
INFORMED CONSENT FORM
For Prospective Research Participants
Please read this consent form carefully and ask as many questions as you like before you decide whether
you want to participate in this research study. You are free to ask questions at any time before, during, or
after your participation in this research.
PROJECT INFORMATION
Project Title: Implementation of Corporate
Organization: Duke Univ., Nicholas School of Environment
Environmental Policies and Strategies
Principal Investigator: DEL-MEM Student name
Phone: +1 XXX-XXX-XXXX
Location: Durham, NC/ Washington, DC area
Other Investigators: None
PURPOSE OF THIS RESEARCH STUDY
You are being asked to participate in a study designed to better understand implementation of corporate
environmental policies and strategies, and linkages to achieving biodiversity conservation. Information
gathered in this survey will be useful in informing the future work of Conservation International, NGOs
engaging business to advance their missions, and companies striving to meet their environmental
responsibilities.
PROCEDURES
You will be asked about your organization’s development and implementation of corporate environmental
policies and strategies. You will be asked about key elements of your environmental policy, the process of
developing your corporate environmental strategy, how your organization is defining and measuring successful
corporate environmental performance, and important internal and external factors contributing to success and
challenges of strategy adoption. You will also be asked whether and how biodiversity risk and conservation
considerations are incorporated into your policy and strategy design and execution, and what biodiversity
conservation results may have been achieved through implementation of your corporate policies and strategies.
USE OF THE RESEARCH MATERIAL
Your responses to the interview questions will be used in a research paper that is a requirement to complete a
master’s degree in environmental management at Duke University.
FINANCIAL CONSIDERATIONS
There is no financial compensation for your participation in this research.
CONFIDENTIALITY
I will ask you to write your name, workplace, and contact information in your survey response. That way I can
contact you if I seek follow-up information, and also I will know which notes pertain to your survey if you
want me to add or delete anything. At the end of the survey, I will ask you if I can use your name and
workplace in my final research paper. Whatever you prefer is fine. In much of my writing, I will describe my
findings without referring to individuals by name, but there may be instances where I would like to attribute a
unique or distinctive idea to the person who said it, if the person has agreed to be identified. If you (or any
other participant) make remarks about other persons, I will not include that individual’s name or position in
the company in either my notes or my paper/publications.
Page 8 of 11 5/27/2004
PARTICIPATION IS VOLUNTARY
You are free to choose whether or not to participate in this study. There will be no negative consequences if
you choose not to participate. You are free to answer questions as briefly or in detail as you wish and to skip
questions. You can decide to stop participating at any time, and you can decide if you want me to keep or
delete the information you have given me.
FOR MORE INFORMATION
Please contact me, the Principal Investigator (contact information at the top of this form), and I will be happy
to answer your questions. You may also contact my advisor with any questions or concerns: Dr. Deborah
Gallagher, [email protected] and 919-613-8138.
If you would like to participate, please fill in the lines below. Please keep the second copy of this sheet so that
you have this information.
Participant Name:______________________________
Date:___________________
Participant Signature: ___________________________
Page 9 of 11 5/27/2004
RESEARCH INSTRUMENTS
Recruitment will consist primarily of an initial email solicitation, and then either a phone call or another email
follow-up after the subject has expressed interest in participating.
Initial Email:
Dear _________:
As you may know, in addition to my job at Conservation International, I am currently in my second year of a twoyear graduate program through Duke University’s Nicholas School of the Environment. My final master’s project
is focusing design and implementation of a select number of company’s environmental policies and strategies,
and linkages to achieving biodiversity conservation.
[For corporate participants, this paragraph applies]: I am interested in learning more about key elements of your
company’s environmental policy and / or strategy, the process of developing that corporate policy or strategy, how
your organization is defining and measuring successful corporate environmental performance, and important
internal and external factors contributing to success and challenges of strategy adoption. My research will also
focus on how biodiversity impacts and conservation considerations are incorporated into your policy and strategy
design and execution, and what biodiversity conservation results may have been achieved through
implementation of your environmental policies and strategies.
[For Conservation International participants, this paragraph applies]: I am interested in learning more about your
work with company X to better understand it and how their corporate environmental policies and strategies are
implemented. In addition, with your help I am hoping to understand if and how CI’s work with company X is
contributing to biodiversity conservation results in our priority regions.
Information gathered in this survey will be useful in informing the future work of Conservation International,
NGOs engaging business to advance their missions, and companies striving to meet their environmental
responsibilities. If you or other colleagues would be interested in contributing to the project, please respond to
this e-mail so I can provide more details. Then, if you decide to participate, I will administer a survey
electronically or by telephone, whichever is most convenient for you and your colleagues.
Thank you for your time and please let me know if you have any questions. I look forward to hearing from you.
Sincerely,
Marielle Canter Weikel
DEL-MEM 08
Nicholas School of the Environment
Interview Questions for corporate interviewees:
1. What are the key elements of your company’s environmental policy and / or strategy?
2. Please describe the process undertaken to develop your company’s environmental strategy.
3. Does your company have a definition of successful environmental performance?
a) If yes, how is successful environmental performance defined?
b) Is environmental performance measured, and if so, how (i.e. reporting on key performance indicators,
etc.)?
c) Does your company report on environmental performance, and if yes, how (i.e. Global Reporting
Initiative, Carbon Disclosure Project, corporate sustainability report, etc.)?
4. Have impacts to biodiversity and conservation considerations been incorporated into your environmental strategy
design and execution?
a) If yes, how have biodiversity impacts and conservation considerations been incorporated?
Page 10 of 11 5/27/2004
5. What, if any, biodiversity conservation results have been achieved through implementation of your company’s
environmental strategy?
6. What are some important factors internal and external to your company that have contributed to success in
implementing your environmental strategy and incorporating biodiversity conservation considerations into project
development?
7. What are some important factors internal and external to your company that have created challenges to
implementing your environmental strategy and incorporating biodiversity conservation considerations into project
development?
8. Please rate how successful your company has been thus far in implementing your environmental strategy, on a
scale of 1 to 5, with 1 being “Not at all successful, our strategy has not been implemented at all” and 5 being
“Completely successful, our strategy has been fully implemented.”
9. Please rate how successful your company has been thus far in integrating biodiversity conservation considerations
into project development, on a scale of 1 to 5, with 1 being “Not at all successful, biodiversity conservation
considerations have not been integrated into project development at all” and 5 being “Completely successful,
biodiversity conservation considerations have been fully integrated into project development.”
10. Please feel free to discuss here any additional information you think is relevant to this study.
Interview Questions for CI interviewees:
1. Please describe the nature of CI’s engagement with company X in location Y, including a brief description of any
partnership objectives and activities.
2. Have impacts to biodiversity and conservation considerations related to the company’s work in location Y been
incorporated into mining project development?
a. If yes, how have biodiversity impacts and conservation considerations been incorporated?
3. What, if any, biodiversity conservation results have been achieved through the company’s work in location Y and /
or their partnership with CI?
4. Please describe any factors internal and external to company X that have created challenges or contributed to their
success in achieving biodiversity conservation results.
5. Please rate how successful company X has been thus far in integrating biodiversity conservation considerations into
mining project development at location Y, on a scale of 1 to 5, with 1 being “Not at all successful, biodiversity
conservation considerations have not been integrated into project development at all” and 5 being “Completely
successful, biodiversity conservation considerations have been fully integrated into project development.”
6. Please feel free to discuss here any additional information you think is relevant to this study.
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